Guckin v. Nagle

• Decision Date: 28 April 2003
• Docket Number: No. CIV.A. 02-5648.,CIV.A. 02-5648.
• Citation: 259 F.Supp.2d 406
• Parties: Eileen GUCKIN & Stephen Guckin, Plaintiffs, v. Deborah NAGLE, et al., Defendants.
• Court: U.S. District Court — Eastern District of Pennsylvania

259 F.Supp.2d 406

Eileen GUCKIN & Stephen Guckin, Plaintiffs, v. Deborah NAGLE, et al., Defendants.

No. CIV.A. 02-5648.

United States District Court, E.D. Pennsylvania.

April 28, 2003.

Alan Milstein, Sherman, Silverstein, Kohl, et al, Pennsauken, NJ, for Eileen Guckin, Stephen Guckin, Plaintiffs.

Paul A. Bechtel, Jr., Marshall Dennehey Warner, Coleman & Goggi, Timothy I. McCann, McCann & Geschke PC, Walter H. Swayze, III, Segal, McCambridge, Singer & Mahoney, Philadelphia, for Deborah Nagle, Individually and as an Employee of Tenet Healthcare Corporation and Graduate Hospital, Inc., Graduate Hospital, Inc., Tenet Healthcare Corporation, Curon Medical, Inc., Defendants.

MEMORANDUM

ROBRENO, District Judge.

Eileen Guckin ("Guckin") and her husband Stephen Guckin brought this personal injury action against defendants Dr. Deborah Nagle, Tenet Healthcare Corporation, Graduate Hospital, Curon Medical, Inc. ("Curon"), and several John Does in state court claiming that she was injured in the course of her participation in the clinical trial of an investigational medical device designed to remedy fecal incontinence. Curon removed the case to this court. Curon asserts that the court has federal question jurisdiction over this matter because (1) Guckin's state law negligence and fraudulent misrepresentation claims inherently raise substantial questions of federal law, (2) the investigatory device exemption to the federal Food, Drug and Cosmetic Act ("FDCA"), under whose auspices Guckin's clinical trial was conducted, creates an area of complete federal preemption such that Guckin's claims are properly federal, not state, in nature, and (3) Curon was allegedly a federal officer empowered to remove the instant case to federal court. Before the court is Guckin's motion to remand.

For the reasons that follow, the court concludes that (1) no substantial federal question is presented in the case because the FDCA, as amended by the Medical Device Amendments ("MDA"), does not provide for a private right of action, (2) the FDCA and MDA do not create an area of complete preemption, such that the state court is barred from hearing Guckin's claims, because the FDCA and MDA do not provide civil remedies for claims that fall within their scope, and there is no clear manifestation of congressional intent to permit removal on the basis that state courts will be forced to interpret federal law, and (3) the defendants in this case are all private parties who are not federal officers empowered to remove the instant case to federal court. Therefore, the court will remand the case to state court.

I. FACTS

The Food, Drug & Cosmetic Act, 21 U.S.C. § 301 et seq., as amended by the Medical Device Amendments of 1976, provides detailed requirements governing the premarket approval process for medical devices for use in humans. See 21 U.S.C. § 360c. Under the FDCA, states are barred from establishing or continuing in effect "with respect to a device intended for human use any requirement ... which is different from, or in addition to, any requirement applicable under this chapter... and which relates to the safety or effectiveness of the device ...." 21 U.S.C. § 360k.

Of all types of medical devices, the FDA reserves the most rigorous premarket approval review for those devices that are identified as "Class III." The reason is that these devices "presen[t] a potential unreasonable risk of illness or injury." 21 U.S.C. § 360c(a)(1)(C)(ii)(II). The "investigational device exemption" ("IDE") to the FDCA provides, however, that new Class III devices may proceed to clinical trials, if the FDA preliminarily examines the technical and scientific evidence, and concludes that the device is safe for further testing. See 21 U.S.C. § 360j(g); 21 C.F.R. § 812. A detailed regulatory scheme specifies how clinical investigations involving new devices are to be monitored, see 21 C.F.R. § 812.2 (summarizing the lengthy IDE requirements set forth in the body of the regulation). 45 C.F.R. § 46 sets forth the protections that are to apply to human subjects engaged in clinical trials.

In the Fall of 2001, Eileen Guckin participated in the clinical trial of the Secca System, a Class III investigational medical device that was manufactured by Curon Medical, Inc., and designed to remedy fecal incontinence. The clinical trial of the Secca System was conducted by principal investigator Deborah Nagle, M.D., a colorectal surgeon employed by Graduate Hospital and Tenet Healthcare, Inc. During the course of this trial, and following implantation of the Secca System, the device allegedly malfunctioned, causing Guckin serious and permanent injuries.

Guckin and her husband Stephen brought the instant action in the Philadelphia County Court of Common Pleas against Dr. Nagle, Graduate Hospital, Tenet Healthcare, Inc., and Curon Medical, Inc. for negligence, assault, battery, lack of informed consent, intentional infliction of emotional distress, negligent infliction of emotional distress, common law fraud, intentional misrepresentation, strict liability in tort, and loss of consortium in connection with Mrs. Guckin's injuries. The Guckins also sued twelve John Does, thus far unidentified members of the Institutional Review Board ("IRB") of Graduate Hospital, which ostensibly approved the Secca System clinical trial, for negligence. Guckin's complaint, on its face, does not purport to rely on any federal law. The parties are non-diverse.

Guckin has moved to remand, arguing that the court lacks subject matter jurisdiction. In opposition to remand, Curon argues that the court has federal question jurisdiction over this matter because (1) Guckin's state law negligence and fraudulent misrepresentation claims inherently raise substantial questions of federal law, (2) the investigatory device exemption to the FDCA under whose auspices Guckin's clinical trial was conducted, constitutes an area of complete federal preemption such that Guckin's claims are properly federal, and not state, in nature, and (3) because Curon is a federal officer empowered to remove the instant case to federal court.

II. DISCUSSION

A. Standard of Review

A district court considering a motion to remand "must focus on the plaintiffs complaint at the time the petition for removal was filed ... [and] must assume as true all factual allegations of the complaint." Steel Valley Auth. v. Union Switch & Signal Div., 809 F.2d 1006, 1010 (3d Cir.1987), cert. dismissed sub nom. American Standard v. Steel Valley Auth., 484 U.S. 1021, 108 S.Ct. 739, 98 L.Ed.2d 756 (1988). The "party who urges jurisdiction on a federal court bears the burden of proving that jurisdiction exists ...." Boyer v. Snap-on Tools Corp., 913 F.2d 108, 111 (3d Cir. 1990); see also Steel Valley Auth., 809 F.2d at 1010 ("It remains the defendant's burden to show the existence and continuance of federal jurisdiction."). Because the removal of an action from the state court to a federal forum implicates comity and federalism, "removal statutes are to be strictly construed against removal and all doubts should be resolved in favor of remand." Steel Valley Auth., 809 F.2d at 1010 (citing Abels v. State Farm Fire & Cas. Co., 770 F.2d 26, 29 (3d Cir.1985)); accord Brown v. Francis, 75 F.3d 860, 865 (3d Cir.1996); Boyer, 913 F.2d at 111.

B. Federal Question Jurisdiction

"`[F]ederal question' cases ... [are] those cases `arising under the Constitution, laws, or treaties of the United States.'" Metropolitan Life Ins. Co. v. Taylor, 481 U.S. 58, 63, 107 S.Ct. 1542, 95 L.Ed.2d 55 (1987) (quoting 28 U.S.C. § 1331). As a general rule, "[t]he presence or absence of federal-question jurisdiction is governed by the `well-pleaded complaint rule,' which provides that federal question jurisdiction exists only when a federal question is presented on the face of the plaintiff's properly pleaded complaint." Caterpillar, Inc. v. Williams, 482 U.S. 386, 392, 107 S.Ct. 2425, 96 L.Ed.2d 318 (1987). In practical effect, the well pleaded complaint rule allows the plaintiff, as "master of the complaint," to choose to avoid a federal forum by "exclusive reliance on state law." Id.

Given that the well pleaded complaint rule allows removal "only when the plaintiff's statement of his own cause of action shows that it is based upon [federal] laws or [the] Constitution," actions are not removable based on the availability of a federal defense to the state law grounded complaint. Bracken v. Matgouranis, 296 F.3d 160, 163 (3d Cir.2002) (quoting Louisville & Nashville R.R. Co. v. Mottley, 211 U.S. 149, 152, 29 S.Ct. 42, 53 L.Ed. 126 (1908)) (emphasis supplied). The rule "applies with full force even when the defense involved is one of federal preemption." Jacob v. SmithKline Beecham, 824 F.Supp. 552, 554 (E.D.Pa.1993) (Robreno J.). The rule is based on a recognition that "[s]tate courts are competent to determine whether state law has been preempted by federal law and they must be permitted to perform that function in cases brought before them, absent a Congressional intent to the contrary." Railway Labor Executives Ass'n v. Pittsburgh & Lake Erie R.R. Co., 858 F.2d 936, 942 (3d Cir.1988).

At the same time, however, "it is an independent corollary to the well-pleaded complaint rule that a plaintiff may not defeat removal by omitting to plead necessary federal questions in a complaint." Franchise Tax Bd. v. Construction Laborers Vacation Trust, 463 U.S. 1, 22, 103 S.Ct. 2841, 77 L.Ed.2d 420 (1983). This corollary, known as the "artful pleading doctrine," allows federal courts to exercise jurisdiction, even when a federal claim does not appear on the face of the plaintiff's complaint, if (1) federal law has completely preempted the state law that serves as the basis for the plaintiff's complaint, or (2) a federal question, not pleaded in the plaintiff's complaint, is nonetheless both intrinsic and central to the plaintiff's cause; of action. 14B Charles A. Wright, Arthur...